23andMe, Inc. is a DNA analysis company backed by Google and their recent announcement that they have become the first genetic test kit maker to recieve full FDA approval is big news for anyone seeking to secure their own health by utilizing the powerful potential of proactive DNA analysis. The U.S. Food and Drug Administration (FDA) will now permit the marketing by 23 And Me of their unique direct-to-consumer genetic test for Bloom Syndrome, a rare genetic condition. Perhaps even more importantly, this new decision by the FDA is likely to be the harbinger of many similar approvals that allow gene test companies to release many other helpful genetic marker test kits for detection of other ailments.
A while ago, the FDA had ordered 23andMe to stop selling its Personal Genome Service (PGS) genetic kit because the kit had not been reviewed and approved yet saying “FDA is concerned about the public health consequences of inaccurate results from the PGS device. The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”
Between 2013 and yesterday, the company worked with the FDA to provide information that demonstrates the accuracy of the kits and now they have earned full FDA approval.
“Specifically this process validated 23andMe’s spit test kit and chip array platform for determining whether or not an individual is a carrier for the genetic markers for Bloom syndrome. In addition, 23andMe conducted extensive comprehension studies with consumers from different backgrounds, education levels and incomes,” 23andMe said in its official statement. “This regulatory process helped establish the parameters for consumer genetics. We are pleased with the Agency’s decision and its affirmation that consumers can understand and benefit from direct access to genetic information,” said Kathy Hibbs, 23andMe’s chief regulatory and legal officer.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers.”
GeneTest.org will continue to provide you with the best information and legally permitted genetic testing solutions.